MAUDE Adverse Event Report: ARTHREX, INC. IMPL SYS,CMC LGMNT RECON; ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Model Number	IMPL SYS,CMC LGMNT RECON
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	02/15/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The contribution of the device to the reported event could not be determined as the device was not returned for evaluation.The root cause of the event could not be determined from the information available and without device evaluation.
Event or Problem Description
It was reported during a ligament reconstruction/ tendon interposition (lrti) of the thumb, the surgeon was attempting to use the ar-1677bc-cp cmc ligament reconstruction system for the first time.The system did not work the way the surgeon had hoped.The surgeon's first complaint was that they could not get the tendon passer ((b)(6) finger trap) to work.After 10 wasted minutes, they finally gave up and used a suture to shuttle the tendon.The second complaint was that the 4.0mm tenodesis screw malfunctioned.The surgeon drilled 4.0mm tunnel and pulled the tendon through.But the screw had no bone purchase and pulled right out.The surgeon attempted a second time but with the same result.The rep offered a 4.75 tenodesis as a back up but the doctor thought it would be too big.Instead the surgeon drilled some bone tunnels and tied the tendon down to bone.The bone quality was soft.

• Brand Name: IMPL SYS,CMC LGMNT RECON
• Common Device Name: ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
• Manufacturer (Section D): ARTHREX, INC.; 1370 creekside boulevard; naples FL 34108 1945
• MDR Report Key: 11436913
• Report Number: 1220246-2021-02690
• Device Sequence Number: 20126276
• Product Code: LXH
• UDI-Device Identifier: 00888867096066
• UDI-Public: 00888867096066
• Combination Product (Y/N): N
• Initial Reporter State: UT
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial
• Report Date (Section B): 03/08/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: IMPL SYS,CMC LGMNT RECON
• Device Catalogue Number: AR-1677BC-CP
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/16/2021
• Initial Report FDA Received Date: 03/08/2021
• Patient Sequence Number: 1